FDA recall Z-1512-2025

Qapel Medical Inc. · Class I · device

Product

Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95

Reason for recall

Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.

Distribution

US: CA, IL, NE, TN, TX, NJ, NC, SD, FL, MI, PA, GA, AL, IN, NY, WI, AZ, MN, LA, OH, OK, SC, NV, ND, ID, MO, CT, WA, MA. OUS: QATAR, United Arab Emirates, Republic of Kazakhstan

Key facts

Status: Ongoing
Initiation date: 2025-02-26
Report date: 2025-04-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2025